VOLUME 11 NUMBER 1
Secundum
Artem
BASICS OF COMPOUNDING
FOR ACNE
GOALS AND OBJECTIVES
Goal: To provide pharmacists, pharmacy students and pharmacy technicians supportive information on the basics of
compounding solutions for the prevention and treatment of acne.
Objectives: After reading and studying the article, the reader will be able to:
1. Explain the causative factors related to acne.
2. Discuss the basic treatment regimens for acne.
3. Describe the various lifestyle factors that can cause acne.
4. List various compounded formulations that are being used in the treatment of acne.
INTRODUCTION
Acne is an inflammatory follicular, papular, and pustular
eruption involving the pilosebaceous apparatus.1 There are
many types of acne with acne vulgaris the most common.
Acne vulgaris is an eruption, predominantly of the face,
upper back and chest, composed of comedones, cysts,
papules and pustules on an inflammatory base. Acne occurs
in almost all individuals at some time or another and is one
of the most widespread medical conditions in the world, yet
there is no cure. It has been said that there is no single condi-
tion that causes more psychic trauma, maladjustment,
general insecurity, feelings of inferiority and other psychic
suffering than acne vulgaris.2
The incidence is approximately 85% between the ages of 12
and 24 years. It typically occurs in males aged 16 to 18 and in
females about a year earlier. In the mid-teen years, papular
lesions generally occur and nodular lesions in the late teens.
By the mid 20s, it generally clears in males but may persist
into the 30s in women and worsen during menopause.3,4 In
the US, it is estimated that 60% of the teenagers use OTC
products to treat acne.5
A CNE FORMATION
Acne is related to hormones, sebum, follicle fallout, bacteria
and inflammation and begins in the pilosebaceous units
(hair follicle and associated sebaceous glands) in the dermis.
Loyd V. Allen, Jr., Ph.D., R.Ph., Professor Emeritus,
University of Oklahoma, HSC College of Pharmacy,
Oklahoma City, OK 73190
Current & Practical Compounding
Information for the Pharmacist.
These units are made up of a hair follicle, sebaceous glands
and a duct (pilosebaceous duct) connecting it to the skin sur-
face through which the hair shaft passes. Epithelial tissue
forms the lining of this shaft. During normal operation, the
sebaceous glands produce sebum that passes to the skin sur-
face through the ducts spreading over the skin to minimize
water loss and to maintain skin and hair hydration. Sebaceous
glands are more common on the face, back and chest, where
acne most often occurs.
During prepuberty, there is relatively little activity from the
sebaceous glands. However, as both males and females
approach puberty, androgenic hormones increase and, as a
result, sebaceous glands are stimulated.
During puberty, an increase in androgens is closely related to
four processes involved in acne development, including (1) an
abnormal keratinization of cells in the pilosebaceous duct, (2)
and increase in sebum production, (3) an accelerated growth
of Propionibacterium acnes, and (4) the occurrence of inflamma-
tion.4,6
With an increase in keratinization of cells shed in the duct and
an increase in their cohesiveness, an obstruction of the follicle
occurs, rather than the normal migration and removal of the
cells from the skin surface. The entrapped and keratinized
cells cause the follicle to expand and form a microcomedo,
which is the beginning of the acne lesion. As the process con-
tinues and additional cells and sebum accumulate, the
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This issue
microcomedo enlarges and becomes visible as a closed come-
do, or whitehead and becomes visible as a small, pale nodule
just beneath the skin surface. This lesion is the precursor to fur-
ther development.
As the lesion progresses and additional material accumulates,
the plug is pushed towards the surface resulting in an open
comedo, or blackhead. The color of the blackhead may be due
to the presence of melanin in the plug. In the duct, P. acnes, an
anaerobic rod and the primary microorganism found in the
duct, undergoes accelerated growth. Through lipase produc-
tion and the breakdown of the sebum to free fatty acids, an
inflammatory reaction occurs, contributing to inflammatory
acne lesions and localized tissue destruction.
As the plug grows and the inflammatory processes continue,
inflammation of the duct wall develops resulting in a disrup-
tion of the epithelial lining and lymphocyte infiltration. If the
follicle ruptures, spontaneously or by squeezing or picking, a
severe inflammatory reaction can occur. During squeezing or
picking, the contents of the plug can be discharged into the
surrounding tissue resulting in abscesses that may result in
scars or pits after healing. Inflammatory acne, with pustules or
purulent nodules, are more likely to cause scarring than non-
inflammatory acne.
Acne is characterized by whiteheads, blackheads, acne pim-
ples and acne blemishes. Closed or open comedones,
(whiteheads and blackheads) are characteristic of noninflam-
matory acne. Typically, a patient with acne will experience a
combination of open and closed comedones, papules and pus-
tules, typically on the face, chest and back but are not limited
to these areas. Pimples are characteristic of inflammatory acne
and are small, prominent, inflamed elevations of the skin.
They may rupture to form papules, which are inflammatory
lesions appearing as raised, reddened areas on the skin. Pus-
tules are small round lesions that are clearly inflamed and
contain visible pus. They may appear red at the base with a
yellowish or whitish center. If the area continues to penetrate
into surrounding and underlying tissue and produce necrotic,
purulent nodular lesions known as cysts, they may lead to pit-
ting and scarring if left untreated.
Scarring is a visible sign of tissue injury and repair when the
tissue cannot be restored to its former state. Scars can be
caused by increased tissue formation and/or by tissue loss.
They can be of several types, including soft, ice-pick,
depressed fibrotic, atrophic macules and follicular macular
atrophy scars. Some scarring can be treated with topical resur-
facing agents, such as retinol, or microdermabrasion.
ACNE CLASSIFICATION
Acne has been classified into the following categories.
Grade I (Comedonal acne) consists of comedones only; less
than about 10 on the face, none on the trunk, no
scarring and noninflammatory in nature.
Grade II (Papular acne) is described by 10-25 papules on the
face and trunk with mild scarring and the presence
of inflammatory lesions, less than 5 mm in
diameter.
Grade III(Pustular acne) consists of more than 25 pustules
with moderate scarring.
Grade IV (Severe or persistent pustulocystic acne) consists of
nodules or cysts with extensive scarring and
inflammatory lesions over 5 mm in diameter. Also,
recalcitrant severe cystic acne characterized with
extensive nodules and/or cysts.
VARIABLES INVOLVED
There are a number of contributing factors to acne, including
environmental, physical, emotional, cosmetic use and heredi-
ty. Environmental factors, such as high humidity and heat
and other conditions that cause frequent and prolonged
sweating can exacerbate acne. Tight fitting clothes that restrict
air movement and prevent evaporation of skin moisture also
increase skin hydration and contribute to acne. Also, acne can
be aggravated by headbands, helmets and friction-producing
devices or positions such as resting the chin or cheek on the
hand often and for long periods of time. Also, exposure to
dirt, cooking oils/vapor/smoke or industrial chemicals such
as petroleum derivatives can cause occupational acne.
Acne resulting from cosmetics is usually of the closed, nonin-
flammatory type and is more common in women. Products
that contain oils (lanolin, mineral oil, cocoa butter) are come-
dogenic, being occlusive and plugging the folicles
exacerbating or even initiating acne. Hair spray can occlude
the pilosebaceous gland and cause acne.
Emotional factors contributing to acne may include severe or
prolonged periods of stress or other emotional extremes, but
will not cause acne.
Hormonal factors are evidenced by premenstrual flare-ups.
Androgenic progestins, as in some oral contraceptives, are
contributors to acne, as are some cyclic progestins used in
menopausal hormone replacement therapy.
Some medications can exacerbate pre-existing acne but will
not actually cause a true acne. Drugs that may contribute to or
induce acne eruptions include corticosteroids (systemic and
topical), androgens, azathioprine, bromides, contraceptives
with a high progestin level, corticosteroids, dantrolene, disul-
firam, ethionamide, haloperidol, halothane, iodides,
isoniazid, lithium, phenytoin (and other hydantoins), quinine,
rifampin, thyroid preparations and trimethadione.
TREATMENT
Acne usually resolves by the mid 20s. Class 2 to 4 acne may
produce scarring but this can be minimized if properly treat-
ed. One of the long-term primary goals in prevention of acne
is to keep the pilosebaceous ducts open and avoid physical
irritation of the skin and oil-based cosmetics and cleansers.
Nonpharmacologic therapy can include cleansing the skin to
remove excess sebum, minimizing exacerbating factors (tight
clothes, irritation, etc.) and not picking or squeezing the
lesions.
Only Grade I (noninflammatory) acne is appropriate for self
treatment with higher grades requiring professional care.
Nonpharmacologic measures include cleansing the skin and
avoiding factors that contribute to acne. Some topical mild
irritants can aid in unblocking pilosebaceous ducts.
Inflammatory acne (Grades II through IV) can require both
OTC and Rx products, including oral and topical antibiotics
and retinoids and exfoliants. Often-used active ingredients
include benzoyl peroxide (2.5 to 10%), salicylic acid (0.5% to
2%), sulfur (3% to 8%) and a combination of sulfur (3-8%) with
either resorcinol (2%) or resorcinol monoacetate (3%), glycol-
ic acid, retinoic acid (0.01% to 0.1%) and various antibiotics,
such as tetracycline and erythromycin. Dosage forms include
solutions, suspensions, sprays, lotions, gels, creams, cleansers,
masks, soaps and bars.
Benzoyl peroxide is a local irritant and causes irritation and
desquamation when applied. It prevents closure of the pilose-
baceous orifice. It’s irritant action increases the rate of
turnover of the epithelial cells lining the follicular duct and
increases sloughing. Benzoyl peroxide also is an oxidizing
agent and has bactericidal and bacteriostatic action that may
inhibit P. acnes from growing, thus reducing the formation of
irritating free fatty acids. Benzoyl peroxide also has irritant,
drying and sensitizing effects.
Salicylic acid is a mild keratolytic used as a safe and effective
agent in preventing and clearing both comedones and inflam-
matory lesions of acne. It increases the rate of desquamation
of the epithelial layer of skin. GELS
Sulfur is a keratolytic in 3 to 10% concentrations and is gen- Rx - BENZOYL PEROXIDE 10% GEL
erally applied as a thin film one to three times daily. Sulfur Benzoyl peroxide 10 g
preparations do have a noticeable color and odor. Propylene glycol 5g
Resorcinol and resorcinol monoacetate in concentrations of Benzyl alcohol 5 mL
1% to 2% have been used. Carbomer 940 0.75 g
Combinations of sulfur and resorcinol act primarily as kera- Trolamine 0.7 mL
tolytics, encouraging cell turnover and desquamation. Ethanol 95% 55 mL
Glycolic acid (hydroxy acetic acid, hydroxyethanoic acid) is Purified water qs 100 mL
used as an agent to enhance desquamation or peeling of the
skin, depending upon the concentration. METHOD OF PREPARATION
Retinoic acid (tretinoin, Vitamin A acid) is a skin irritant. It is 1. Calculate the required quantity of each ingredient for the total
used primarily in the treatment of acne vulgaris in which amount to be prepared.
comedones, papules and pustules predominate. It is general- 2. Accurately weigh/measure each ingredient.
ly applied as a cream, gel or alcoholic solution in 3. Dissolve the benzoyl peroxide in the benzyl alcohol.
concentrations ranging from 0.01% to 0.1%. The skin is thor- 4. Add the propylene glycol with rapid mixing; then add the
oughly cleansed to remove oiliness about 15-30 minutes prior carbomer 940.
to application of the tretinoin, once or twice daily. 5. Slowly add about 40 mL of purified water and mix until
Tetracycline hydrochloride is a broad spectrum bacteriostat- uniform.
ic antibiotic that is used topically in concentrations of 0.2% 6. Slowly add the alcohol, followed by the trolamine and mix
solution for acne. It is also used orally at a dose of 250 mg well.
twice daily for systemic treatment of acne. 7. Add sufficient purified water to volume and mix well.
Erythromycin is a macrolide antibiotic that is primarily bac- 8. Package and label.
teristatic against a broad range of bacteria. Erythromycin is
used orally and topically (2%) in the treatment of severe acne. STABILITY
Ethyl and isopropyl alcohol are often used as vehicles and A beyond-use date of 6 months can be used for this formulation.7
will evaporate rapidly after application to the skin. This
results in a film of the active drug remaining on the skin sur- Rx - ERYTHROMYCIN 2% GEL
face to exert its effect. Erythromycin 2g
Dosage form selection should include those delivery systems Propylene glycol 24 mL
that are noncomedogenic. Gels tend to be most effective but Hydroxypropyl cellulose 1500 cps 2g
some patients may need the less drying lotions or creams for Ethyl alcohol 70% qs 100 mL
dry or sensitive skin or for use during dry winter weather.
Gels containing only water tend to be slow to dry; the addi- METHOD OF PREPARATION
tion of ethyl or isopropyl alcohol to the gel hastens their 1. Calculate the required quantity of each ingredient for the total
drying to a film. Gelling agents should not leave a sticky film amount to be prepared.
and should be thin and colorless, thus eliminating the need 2. Accurately weigh/measure each ingredient.
for coloring to blend the product to the color of the skin. Gen- 3. Dissolve the erythromycin in about 70 mL of the ethyl alcohol
erally, gels can be recommended for those with darker 70%.
complexions and creams for those with fair complexions. 4. Add the propylene glycol and mix well.
5. Slowly sprinkle the hydroxypropyl cellulose on to the agitated
solution and stir until gelling occurs.
EXAMPLES OF COMPOUNDED PREPARATIONS FOR ACNE 6. Add sufficient ethyl alcohol 70% to volume and mix well.
7. Package and label.
CREAMS STABILITY
Rx - BENZOYL PEROXIDE 10% CREAM A beyond-use date of 6 months can be used for this formulation.7
Benzoyl peroxide 10 g
Benzyl alcohol 10 g Rx - GLYCOLIC ACID 15% GEL
Polysorbate 80 4g Glycolic Acid 70% 21.5 mL
Hydrophilic ointment qs 100 g Methocel E4M Premium 3g
Xanthan gum 600 mg
METHOD OF PREPARATION Methylparaben 50 mg
1. Calculate the required quantity of each ingredient for the Propylparaben 25 mg
total amount to be prepared. Purified water qs 100 mL
2. Accurately weigh/measure each ingredient. METHOD OF PREPARATION
3. Mix the benzoyl peroxide with the benzyl alcohol. 1. Calculate the required quantity of each ingredient for the total
4. Using low heat, melt the hydrophilic ointment and add the amount to be prepared.
polysorbate 80. 2. Accurately weigh/measure each ingredient.
5. Add the benzoyl peroxide and benzyl alcohol mixture and 3. Heat about 70 mL of purified water to boiling and add the
mix well. methylparaben and propylparaben.
6. Cool with stirring, package and label. 4. With agitation, sprinkle on the Methocel E4M Premium and the
xanthan gum.
STABILITY 5. Cool and incorporate the glycolic acid.
A beyond-use date of 6 months can be used for this formula- 6. Add sufficient purified water to volume and mix well.
tion.7 7. Package and label.
STABILITY 4. Dissolve the resorcinol in the anhydrous alcohol (this is
A beyond-use date of 6 months can be used for this formu- a slow process).
lation.7 5. Add the salicylic acid:lactic acid solution slowly with
stirring and mix well.
Rx - SULFUR AND RESORCINOL GEL 6. Add sufficient alcohol USP to volume and mix well.
Sulfur 5g 7. Package in a tight, light-resistant container and label.
Resorcinol 2g
Propylene glycol qs STABILITY
Methylparaben 75 mg A beyond-use date of 6 months can be used for this for-
Carbopol 940 500 mg mulation.7
Trolamine 0.67 mL Rx - RESORCINOL 3%, SALICYLIC ACID 2%
Alcohol USP 12.5 mL & LACTIC ACID 4% PEEL
Purified water qs 100 mL Resorcinol 3g
Salicylic acid 2g
METHOD OF PREPARATION Lactic acid 88% 4.6 g
1. Calculate the required quantity of each ingredient for the Alcohol USP 50 mL
total amount to be prepared. Purified water qs 100 mL
2.Accurately weigh/measure each ingredient.
3. Dissolve the resorcinol in the alcohol and slowly METHOD OF PREPARATION
incorporate the carbopol 940 by sprinkling it on with 1. Calculate the required quantity of each ingredient for the
agitation. total amount to be prepared.
4. Dissolve the trolamine and methylparaben in about 80 2. Accurately weigh/measure each ingredient.
mL of purified water. 3. Dissolve the resorcinol in the purified water.
5. Combine the two liquids with mixing. 4. Dissolve the salicylic acid in the alcohol, followed by the
6. Make a paste of the sulfur with the propylene glycol and lactic acid and mix well.
slowly incorporate into the gel and mix well. 5. Add the two solutions together.
7. Add sufficient purified water to volume and mix well. 6. Add sufficient purified water to volume and mix well.
8. Package and label. 7. Package in an amber container and label.
STABILITY STABILITY
A beyond-use date of 6 months can be used for this formu- A beyond-use date of 6 months can be used for this for-
lation.7 mulation.7
Rx - RETINOIC ACID 0.2% SOLUTION
OINTMENTS Retinoic acid 200 mg
Rx - RETINOIC ACID 0.2% IN PEG OINTMENT BHT 200 mg
Alcohol USP 60 mL
Retinoic acid 200 mg Polyethylene glycol 300 qs 100 mL
Butylated hydroxytoluene 800 mg
Polyethylene glycol 1540 70 g METHOD OF PREPARATION
Polyethylene glycol 300 qs 100 g 1. Calculate the required quantity of each ingredient for the
total amount to be prepared.
METHOD OF PREPARATION 2. Accurately weigh/measure each ingredient.
1. Calculate the required quantity of each ingredient for the 3. Dissolve the retinoic acid and the butylated
total amount to be prepared. hydroxytoluene in the alcohol. USP.
2. Accurately weigh/measure each ingredient. 4. Add sufficient polyethylene glycol 300 to volume and
3. Dissolve the retinoic acid and the butylated mix well.
hydroxytoluene in the polyethylene glycol 300. 5. Package and label.
4. Melt the polyethylene glycol 1540 at about 55º C.
5. Add the retinoic acid and BHT solution to the melted STABILITY
base, mix well and allow to cool. A beyond-use date of 6 months can be used for this for-
6. Package and label. mulation.7
STABILITY Rx - TETRACYCLINE HCL 2% TOPICAL SOLUTION
A beyond-use date of 6 months can be used for this formu- Tetracycline HCl 2.2 g
lation.7 Alcohol USP 45 mL
Isopropyl alcohol anhydrous 99% 5 mL
SOLUTIONS Citric acid
Sodium bisulfite
100 mg
100 mg
Rx - JESSNER’S SOLUTION Purified water qs 100 mL
Salicylic acid 14 g
Resorcinol 14 g METHOD OF PREPARATION
Lactic acid 88% 14 mL 1. Calculate the required quantity of each ingredient for the
Alcohol, anhydrous 12 mL total amount to be prepared.
Alcohol USP qs 100 mL 2. Accurately weigh/measure each ingredient.
3. Mix the alcohol USP and the isopropyl alcohol.
METHOD OF PREPARATION
4. Dissolve the tetracycline HCl, citric acid and sodium
1. Calculate the required quantity of each ingredient for the
bisulfite in the solution.
total amount to be prepared.
5. Add sufficient purified water to volume and mix well.
2. Accurately weigh/measure each ingredient.
6. Package in a tight, light-resistant container and label.
3. Dissolve the salicylic acid in about 45 mL of the alcohol
USP, then add the lactic acid.
STABILITY
A beyond-use date of 6 months can be used for this for- REFERENCES
mulation.7 1. Spraycar M. Ed. Stedman's Medical Dictionary, 26th ed.
Baltimore, Williams & Wilkins. 1995, p 16.
2. Sluzberger MB and Zaidems SH. Psychogenic factors in
SUSPENSIONS/LOTIONS dermatological disorders. Medical Clinics of North
America, 1948; 32: 669.
Rx - SULFUR AND SALICYLIC ACID SUSPENSION 3. Somnath P. 17 million persons have acne vulgaris. U.S.
Sulfur 5g Pharm. April 1997;22(4): 15.
Salicylic acid 2g 4. Rothman KF, Lucky AW. Acne vulgaris. Adv Dermatol.
Propylene glycol 10 mL
Alcohol USP 10 mL 1993;8:347-75.
Methylcellulose 1500 cps 2 g 5. Gossel TA. OTC anti-acne medications. US Pharm.
Methylparaben 50 mg October 1990;15:24-34.
Propylparaben 25 mg 6. Hurwitz S. Acne vulgaris: pathogenesis and
Purified water qs 100 mL management. Pediatrics Rev. February 1994;15(2):47-52.
7. US Pharmacopeial Convention, Inc. United States
METHOD OF PREPARATION Pharmacopeia 24/National Formulary 19. Rockville,
1. Calculate the required quantity of each ingredient for MD: US Pharmacopeial Convention, Inc.; 2001, pp2053-
the total amount to be prepared. 2057.
2. Accurately weigh/measure each ingredient.
3.Dissolve the methylparaben and the propylparaben in a
mixture of the propylene glycol and alcohol.
NOTES__________________________________________
4. Incorporate the sulfur and salicylic acid. ___________________________________________________
5.Heat about 25 mL of purified water to boiling and
slowly sprinkle on the methylcellulose. ___________________________________________________
6.Add about 25 mL of ice-cold purified water to step #5
and mix well. ___________________________________________________
7.Incorporate the mixture from step #4 into the ___________________________________________________
methylcellulose dispersion and mix well.
8.Package and label. ___________________________________________________

STABILITY ___________________________________________________
A beyond-use date of 6 months can be used for this for- ___________________________________________________
mulation.7
___________________________________________________
Rx - ZINC SULFIDE COMPOUND LOTION
(WHITE LOTION) ___________________________________________________
Zinc sulfate 4g
___________________________________________________
Sulfurated potash 4g
Purified water qs 100 mL ___________________________________________________

METHOD OF PREPARATION ___________________________________________________

1.Calculate the required quantity of each ingredient for ___________________________________________________
the total amount to be prepared.
2. Accurately weigh/measure each ingredient. ___________________________________________________
3.Dissolve the zinc sulfate in about 45 mL of purified
water. ___________________________________________________
4.Dissolve the sulfurated potash in about 45 mL of ___________________________________________________
purified water.
5.Filter each solution separately. ___________________________________________________
6.Slowly and with constant stirring, add the sulfurated
potash solution to the zinc sulfate solution. ___________________________________________________
7.Add sufficient purified water to volume and mix well. ___________________________________________________
8.Package and label.
___________________________________________________
STABILITY
A beyond-use date of 6 months can be used for this for-
mulation.7
 Send this completed form in for CE credit Today!
Please circle the most appropriate answer for each of the following questions. There is only ONE correct answer per question.
1. Acne appears to be related to: 8. Which of the following does not increase the rate of
A.hormones desquamation of the cells.
B.sebum A.benzoyl peroxide
C.follicle fallout B.salicylic acid
D.bacteria C.glycolic acid
E.all the above D.tetracycline hydrochloride
E. none of the above
2. Acne appears to be somewhat related to the level of circulating
androgens in the body. 9. Which of the following dosage forms appears to be the “best”
A.True for treating acne.
B.False A.ointments
B.creams
3. What is the primary component involved in the obstruction of the C.gels
follicle? D.oils
A.sebum E.none of the above.
B.perspiration
C.white blood cells 10. The addition of which of the following will increase the rate
D.shed epithelial cells of drying of a gel upon application to the skin.
E.hair follicles A.alcohol
B.glycerin
4. What is the beginning of the acne lesion? C.propylene glycol
A.microcomedo D.purified water
B.comedo E.sesame oil
C.nodule
D.papule 11. My practice setting is:
E.pustule
A. Community-based C. Hospital-based
B. Managed care-based D. Consultant and other
5. High humidity and heat can contribute to the development of acne.
A.true 12. The quality of the information presented in this article was:
B.false
A. Excellent B. Good C. Fair D. Poor
6. Grade III acne can be easily and safely treated with only
nonprescription products. 13. The test questions correspond wellwiththe informationpresented.
A.true A. Yes B. No
B.false
14. Approximately how long did it take you to read the Secundum Artem
7.What concentration of benzoyl peroxide is commonly used?
A.0.1 to 0.5% article AND respond to the test questions?_________________________
B.0.5 to 1%
C.1 to 2.5% 15. What topics would you like to see in future issues of Secundum
D.2.5 to 10%
E.10 to 25% Artem? __________________________________________________

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